Progenity Inc.

Patent Trials and Appeals Board

Jan 11, 2022

2021002244 (P.T.A.B. Jan. 11, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/835,270 12/07/2017 Mitchell Lawrence Jones 128683-0006UT02 1808 181087 7590 01/11/2022 PROGENITY / PCHS 525 B STREET SUITE 2200 SAN DIEGO, CA 92101 EXAMINER MARTIN, PAUL C ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 01/11/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): PTONotifications@procopio.com Patents@progenity.com docketing@procopio.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ________________ Ex parte MITCHELL LAWRENCE JONES, CHRISTOPHER LOREN WAHL, MARK SASHA DRLIK, and NICHOLAS DAVID ALLAN1 ________________ Appeal 2021-002244 Application 15/835,270 Technology Center 1600 ________________ Before RICHARD M. LEBOVITZ, JOHN G. NEW, and TAWEN CHANG, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 We use the term “Appellant” to refer to the “applicant” as defined in 37 C.F.R. § 1.142. Appellant identifies Progenity, Inc. as the real party-in- interest. App. Br. 1. Appeal 2021-002244 Application 15/835,270 2 SUMMARY Appellant files this appeal under 35 U.S.C. § 134(a) from the Examiner’s Non-Final Rejection of claims 1, 166, 167, 169, 170, 174-183, and 185-194. Specifically, claims 1, 166, 167, 169, 170, 174-178 and 181 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Bucalo (US 3,998,211, December 21, 1976) (“Bucalo”), and Sprenkels et al. (US 2007/0161928 A1, July 12, 2007) (“Sprenkels”). Claims 1, 166, 167, 169, 170, 174-178, 181, and 186 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Bucalo, Sprenkels, and Tang et al. (US 2005/0154277 Al, July 14, 2005) (“Tang”). Claims 1, 166, 167, 169, 170, 174-183, 185, 187, 188, and 191 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Bucalo, Sprenkels, and U.C. Ghoshal et al., Irritable Bowel Syndrome and Small Intestinal Bacterial Overgrowth: Meaningful Association or Unnecessary Hype, 20(10) WORLD J. GASTROENTEROL. 2482-91 (2014) (“Ghoshal”). Claims 1, 166, 167, 169, 170, 174-183, 185, 187, 188, 189, 191, and 192 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Bucalo, Sprenkels, Ghoshal, and Andresen (US 5,247,941, September 28, 1993) (“Andresen”). Claims 1, 166, 167, 169, 170, 174-183, 185, 187, 188, 190, 191, and 193 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Bucalo, Sprenkels, Ghoshal, and Amoako-Tuffour et al. (US 2015/0011874 A1, January 8, 2015) (“Amoako-Tuffour”). Appeal 2021-002244 Application 15/835,270 3 Claims 1, 166, 167, 169, 170, 174-178, 181, 186, and 194 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Bucalo, Sprenkels, and Bucalo (US 4,325,388, April 20, 1982) (“Bucalo 2”). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellant’s claimed invention is directed to gastrointestinal (GI) tract detection methods and devices. Spec., Abstr. REPRESENTATIVE CLAIM Independent claim 1 is representative of the claims on appeal and recites: 1. A method, comprising: transferring a fluid sample from the gastrointestinal (GI) tract of a subject into a first dilution chamber of an ingestible device in vivo; combining the fluid sample and a first dilution fluid in the first dilution chamber to produce a first diluted sample; and culturing the first diluted sample to produce a cultured sample, wherein the culturing is performed in vivo. App. Br. 5. Appeal 2021-002244 Application 15/835,270 4 ISSUE AND ANALYSIS We agree with and adopt the Examiner’s findings, reasoning, and conclusion that the claims are obvious over the combined cited prior art. We address below the arguments raised by Appellant. A. Claims 1, 166, 167, 169, 170, 174-183, 185, 186, and 191-193 The Examiner’s Findings and Conclusions The Examiner finds that Bucalo teaches a method comprising: transferring a fluid sample from a body cavity (such as the reproductive tract) into a first dilution chamber of a device in vivo, combining the sample with a first dilution fluid (liquid growth medium) in the first dilution chamber to produce a first diluted sample and culturing the first diluted sample in vivo to produce a cultured sample. Non-Final Act. 3 (citing Bucalo col. 5, ll. 16-31, col. 6, ll. 32-37, 47-65). The Examiner acknowledges that Bucalo does not teach or suggest a method in which the device comprises a plurality of dilution chambers; and for each at least some of the plurality of dilution chambers, the method comprises: transferring a fluid sample into the dilution chamber; and combining the fluid sample and the first dilution fluid in the first dilution chamber to produce a diluted sample, as required by Claim 166. Non-Final Act. 4. However, the Examiner finds that Sprenkels teaches a method of sampling a liquid from a human or animal body in vivo comprising administering a device, wherein the liquid is gastrointestinal liquid, lymph, or blood. Id. (citing Sprenkels 17, claims 27-28). The Examiner also finds that Sprenkels teaches that its device is swallowable/ingestible, that the device comprises a first dilution chamber in Appeal 2021-002244 Application 15/835,270 5 which the fluid sample and first dilution liquid from a reservoir are combined to produce a diluted sample, and in which the dilution liquid is a quenching or stabilizing liquid/media. Non-Final Act. 5 (citing Sprenkels, ¶¶ 28, 43, Fig. 2). The Examiner further finds that the device can be used to detect an analyte in the sample (microbial/cell metabolites). Id. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art to combine the method and device for in vivo sampling and culturing from a body cavity of Bucalo with the use of an ingestible method and device for sampling fluids from the gastrointestinal tract as taught by Sprenkels, because this is no more than the use of a known technique (ingestible device to sample bodily fluids in vivo) to improve a similar device/method (device for sampling/culturing bodily fluids in vivo) in the same way. Non-Final Act. 5. The Examiner further concludes that it would have been obvious to a skilled artisan to utilize the combined device/method of Bucalo and Sprenkels with a sterile medium for diluting the sample, as this would prevent contamination of the sample. Id. at 6. The Examiner reasons that a person of ordinary skill in the art would have been motivated to make this modification because certain bacteria species need to be cultured at a minimal concentration to proliferate, for example. Non-Final Act. 7. The Examiner finds that a person of ordinary skill in the art would have had a reasonable expectation of success in making this combination/modification because both references are drawn to the same field of endeavor, viz., sampling bodily fluids in vivo with a sampling device. Id. Appeal 2021-002244 Application 15/835,270 6 Issue Appellant argues that the Examiner erred because Bucalo does not teach or suggest the claimed method of transferring a sample of fluid from the GI tract of a subject into an ingestible device. App. Br. 2. Analysis Appellant contends that Bucalo teaches a device that enters a subject via the vaginal tract, after which the device is manually operated from outside the subject. App. Br. 2 (citing, e.g., Bucalo, col. 4, ll. 21-38, cols. 4-5, ll. 67-8, Fig. 2). Appellant therefore contends that Bucalo’s device is not an ingestible device into which a sample of gastrointestinal fluid from a subject could be transferred. Id. Appellant asserts that, given the substantial differences between the subject matter recited by independent claim 1 and that disclosed in Bucalo, it could only be impermissible hindsight reasoning upon the part of the Examiner that would result in a conclusion that independent claim 1 is obvious, based on Bucalo as the primary reference. Id. Appellant further contends that the alleged infirmities of Bucalo are not cured by the other references cited by the Examiner. Id. We are not persuaded by Appellant’s arguments that the Examiner erred. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the Appeal 2021-002244 Application 15/835,270 7 references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981). We acknowledge that Bucalo does not expressly teach an ingestible device for sampling fluids from the gastrointestinal tract, although Bucalo does teach: According to the invention an enclosure, which has a suitable nutrient in its interior, is introduced into a body cavity in such a way that a part of the enclosure is located in the immediate vicinity of a location where it is suspected that certain microorganisms are present while the nutrient is normally situated beneath this part of the enclosure. With the enclosure thus situated in the body cavity, conditions are created for transferring a microorganism from the location where the presence thereof is suspected into the interior of the enclosure into contact with the nutrient therein. After the enclosure remains in the body for a time sufficient for growth of a culture in the nutrient from the suspected microorganisms, the enclosure is removed and then the nutrient may be checked for determination of the presence or absence of the suspected microorganism. Bucalo col. 2, ll. 42-57 (emphasis added). We agree with the Examiner that a “body cavity” would include the lumen of the gastrointestinal tract and that the process of “introducing” the device into a body cavity is the same as ingesting it or would reasonably suggest ingesting it. But we need not rely exclusively upon Bucalo as teaching this limitation. Sprenkels expressly teaches that “[t]he present invention relates to a sampling device suitable for in vivo sampling of liquid(s) from the gastro-intestinal tract.” Sprenkels Abstr. Sprenkels further teaches that Appeal 2021-002244 Application 15/835,270 8 “[s]ampling devices for sampling liquids from the GI tract (gastrointestinal tract) are known in the art” and that: The term “swallowable” refers to the dimensions of the device, especially of the device in a form to be swallowed (e.g.[,] included in a tablet or on a carrier) which can[,] e.g.[,] be swallowed by a predetermined group of humans (e.g.[,] a number of adults such as 10 adults of 25-75 years) or animals (for example a number of animals such as 5 beagle dogs of 1 year). This means that the term “swallowable” may be related to a predetermined group of patients, such as adults, children, etc. As will be clear to the person skilled in the art, the term “swallowable” refers to dimensions of the device or of an assembly of the device in a container or on a carrier (like a tablet) which dimensions are selected such that the device or assembly, respectively is suitable for oral administration for one or more target persons (adult, child, etc.). Id. at ¶¶ 2, 28. Sprenkels also teaches that: In a specific embodiment, there is provided a device wherein body 10 further comprises a reservoir 70 with a reservoir filling channel 72 and a connection channel 74 connecting reservoir 70 and channel 30. Reservoir 70 may be used to contain a quenching liquid or stabilizing liquid. While GI liquid travels from inlet or opening 21 in the direction of second end 26, GI liquid is contacted with liquid from reservoir 70. Hence, liquid from reservoir 70 will also travel in the direction of second end 26 induced by GI liquid transport in channel 30. Sprenkels ¶ 43. We consequently find that the combination of Bucalo and Sprenkels suggests and makes obvious the claimed method of transferring a sample of fluid from the GI tract of a subject into an ingestible device, and we reject Appellant’s arguments as being without merit. Appeal 2021-002244 Application 15/835,270 9 B. Independent claims 187 and dependent claims 188-190 Issue Appellant argues that the Examiner erred because Bucalo neither teaches nor suggest the limitations of claim 187 requiring transferring a sample of jejunal fluid from the gastrointestinal tract of a subject into a first dilution chamber of an ingestible device in vivo. App. Br. 3. Analysis Appellant largely repeats the arguments set forth with respect to, inter alia, claim 1 supra. Id. Specifically, Appellant argues that Bucalo teaches a device that enters a subject via the vaginal tract, after which the device is manually operated from outside the subject. Id. We have explained why we are not persuaded by Appellant’s arguments in this respect, and we incorporate by reference those arguments with respect to claims 187-190. For these same reasons, we are again not persuaded by Appellant’s arguments that the Examiner erred. C. Claim 194 Issue Appellant argues that the Examiner erred because Bucalo neither teaches transferring a fluid sample from the gastrointestinal (GI) tract or from the reproductive tract of a subject into a dilution chamber of a device in vivo. Appeal 2021-002244 Application 15/835,270 10 Analysis Appellant again argues that Bucalo teaches a device that enters a subject via the vaginal tract, after which the device is manually operated from outside the subject. App. Br. 4. We disagree, for the reasons we have explained supra. Specifically, and as we have explained, Sprenkels expressly teaches that “[t]he present invention relates to a sampling device suitable for in vivo sampling of liquid(s) from the gastro-intestinal tract” and further teaches that such devices are known in the art. Sprenkels Abstr., ¶ 2. For the reasons we have explained, we are consequently not persuaded by Appellant’s arguments the Examiner erred. CONCLUSION The rejection of claims 1, 166, 167, 169, 170, 174-183, and 185-194 as unpatentable under 35 U.S.C. § 103 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1, 166, 167, 169, 170, 174-178, 181 103 Bucalo, Sprenkels 1, 166, 167, 169, 170, 174-178, 181 Appeal 2021-002244 Application 15/835,270 11 Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1, 166, 167, 169, 170, 174-178, 181, 186 103 Bucalo, Sprenkels, Tang 1, 166, 167, 169, 170, 174-178, 181, 186 1, 166, 167, 169, 170, 174-183, 185, 187, 188, 191 103 Bucalo, Sprenkels, Ghoshal 1, 166, 167, 169, 170, 174-183, 185, 187, 188, 191 1, 166, 167, 169, 170, 174-183, 185, 187, 188, 189, 191, 192 103 Bucalo, Sprenkels, Ghoshal, Andresen 1, 166, 167, 169, 170, 174-183, 185, 187, 188, 189, 191, 192 1, 166, 167, 169, 170, 174-183, 185, 187, 188, 190, 191, 193 103 Bucalo, Sprenkels, Ghoshal, Amoako- Tuffour 1, 166, 167, 169, 170, 174-183, 185, 187, 188, 190, 191, 193 1, 166, 167, 169, 170, 174-178, 181, 186, 194 103 Bucalo, Sprenkels, Bucalo 2 1, 166, 167, 169, 170, 174-178, 181, 186, 194 Overall Outcome 1, 166, 167, 169, 170, 174-183, 185- 194